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EVOREL is a brand name for Estradiol (also known as Oestradiol). The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Hormone Replacement Therapy (HRT) for estrogen deficiency symptoms in postmenopausal women. The experience treating women older than 65 years is limited.
Verbatim from this product's MHRA label. Tap a section to expand.
Two therapeutic regimens can be used: 1. Cyclic: for 24 to 28 days, followed by a 2 to 7 days treatment free period. The progestogen should be administered at least during the last 12 days of the estradiol treatment in non- hysterectomised women.
Withdrawal bleeding may occur during this period. 2. Continuous: with no treatment free period. In non-hysterectomised women the progestogen should be administered for at least 12 days per month. Withdrawal bleeding may occur when the progestogen is withdrawn.
3. Continuous, non-cyclic, treatment may be recommended in cases where marked symptoms of estrogen deficiency recur during the treatment-free period. 4. In women with an intact uterus the addition of a progestogen for at least 12 to 14 days per cycle is essential to help prevent any endometrial hyperplasia induced by the estrogen.
For more detailed information, please refer to section "Special warnings and precautions for use" – Endometrial hyperplasia). 5. In hysterectomised women, unless there is a previous diagnosis of endometriosis, the addition of a progestogen is not recommended.
5 g of Evorel Gel. 5 mg Estradiol) is the usual starting dose for 24 to 28 days. This starting dose can be adapted per the patients’ individual needs. 5 g) of Evorel Gel per day, which in the majority of women will provide effective relief of symptoms.
If after one month's treatment effective relief is not obtained, the dosage may be increased accordingly to a maximum of six pumps (3 g) of Evorel Gel daily (3 mg Estradiol). The lowest effective dose should be used for maintenance therapy.
4) should be used. Use with progestogen In women with an intact uterus the addition of a progestogen for at least 12 to 14 days per cycle is essential to help prevent any endometrial hyperplasia induced by the estrogen. In hysterectomised women, unless there is a previous diagnosis of endometriosis, the addition of a progestogen is not recommended.
Initiation of treatment Women who have never taken HRT and are post-menopausal or have very infrequent menstrual cycles: treatment with Evorel Gel can be started on any day. Switching from a continuous oestrogen-progestogen combined HRT: treatment with Evorel Gel can be started on any day of the cycle.
Switching from a cyclic or continuous sequential HRT treatment: finish the therapeutic sequence before beginning treatment with Evorel Gel. Method of Administration It may be necessary to prime the pump when beginning a new bottle. The pump must be pressed several times until gel comes out of the pump.
Serious undesirable effects associated with the use of hormone replacement therapy are also mentioned in section "Special warnings and precautions for use". Tabulated list of adverse reactions The table below reports undesirable effects that have been reported in users of hormone replacement therapy (HRT) by MedDRA system organ classes (MedDRA SOCs).
System organ class Common ( 1/100; < 1/10) Uncommon ( 1/1,000; < 1/100) Rare ( 1/10,000; <1/1,000) Immune system disorders Hypersensitivity reaction Metabolism and nutrition disorders Weight increase or weight decrease Psychiatric disorders Depressed mood Anxiety, Libido decreased or Libido increased Nervous system disorders Headache Dizziness Migraine Eye disorders Visual disturbances Contact lens intolerance Cardiac disorders Palpitations Gastrointestinal disorders Abdominal pain, Nausea Dyspepsia Bloating, Vomiting Skin and subcutaneous tissue disorders Rash, Pruritus Erythema nodosum, Urticaria Hirsutism, Acne Musculoskeletal and connective tissue disorders Muscle cramps Reproductive system and breast disorders Uterine/Vaginal bleeding including Spotting Breast pain, Breast tenderness Dysmenorrhea, Vaginal discharge, Premenstrual- like syndrome, Breast enlargement General disorders and administration site conditions Oedema Fatigue The most appropriate MedDRA term is used to describe a certain reaction and its synonyms and related conditions.
Breast cancer risk • An up to 2-fold increased risk of having breast cancer diagnosed is reported in women taking combined estrogen-progestogen therapy for more than 5 years. • The increased risk in users of estrogen-only therapy is lower than that seen in users of estrogen- progestogen combinations.
4). • Absolute risk estimation based on the results of the largest randomized placebo-controlled trial (WHI- study) and the largest meta-analysis of prospective epidemiological studies are presented. 0 * Taken from baseline incidence rates in England in 2015 in women with BMI 27 (kg/m2) Note: Since the background incidence of breast cancer differs by EU country, the number of additional cases of breast cancer will also change proportionately.
For the treatment of postmenopausal symptoms, HRT should only be initiated for symptoms that adversely affect quality of life. In all cases, a careful appraisal of the risks and benefits should be undertaken at least annually and HRT should only be continued as long as the benefit outweighs the risk.
Evidence regarding the risks associated with HRT in the treatment of premature menopause is limited. Due to the low level of absolute risk in younger women, however, the balance of benefits and risks for these women may be more favourable than in older women.
Medical examination/follow-up Before initiating or reinstituting HRT, a complete personal and family medical history should be taken. Physical (including pelvic and breast) examination should be guided by this and by the contraindications and warnings for use.
During treatment, periodic check-ups are recommended of a frequency and nature adapted to the individual woman. Women should be advised what changes in their breasts should be reported to their doctor or nurse (see “Breast cancer” below).
g. mammography, should be carried out in accordance with currently accepted screening practices, modified to the clinical needs of the individual. Conditions which need supervision If any of the following conditions are present, have occurred previously, and/or have been aggravated during pregnancy or previous hormone treatment, the patient should be closely supervised.
It should be taken into account that these conditions may recur or be aggravated during treatment with EVOREL GEL, in particular: • Leiomyoma (uterine fibroids) or endometriosis. • Risk factors for thromboembolic disorders (see below).
g. 1st degree heredity for breast cancer. • Hypertension. g. liver adenoma). • Diabetes mellitus with or without vascular involvement. • Cholelithiasis. • Migraine or (severe) headache. • Systemic lupus erythematosus. • A history of endometrial hyperplasia (see below).
• Known, past or suspected breast cancer. g. endometrial cancer). • Undiagnosed genital bleeding. • Untreated endometrial hyperplasia. • Previous or current venous thromboembolism (deep venous thrombosis, pulmonary embolism). g. 4). g. angina, myocardial infarction).
• Acute liver disease, or a history of liver disease as long as liver functions have failed to return to normal. 1. • Porphyria.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Estradiol in United Kingdom.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
The first dose may not be accurate and should be discarded. The pump may need to be reprimed after first use. g. on the arms and shoulders, or inner thighs, preferably after washing in the morning or evening. The area of application should be at least 2 times the size of the hand.
Evorel Gel should NOT be applied on or near the breasts or on the vulval region. A frequent change in application sites is recommended. It is not necessary to rub Evorel Gel in, however, it should be allowed to dry for 2 minutes before covering the skin with clothing.
Women should cover the application site with clothing if another person may come into contact with the area of skin after the gel dries. The site of application should not be washed for 60 minutes. 4).
For people not being treated with Evorel Gel:
In the event of contact with an application area, which has not been washed or is not covered with clothing, wash the area of skin onto which Evorel Gel may have been transferred as soon as possible, using soap and water. If the patient forgets to apply a dose and it is more than 12 hours until the next dose, the missed dose should be applied and normal dosing resumed the next day.
If the next dose is less than 12 hours away, it is best just to wait and apply the next dose normally. Patients should be advised not to apply two doses at the same time. Forgetting a dose may increase the likelihood of break-through bleeding and spotting.
The individual dose can be adjusted to individual needs. 5 g to 3 g of gel. e. 3 consecutive doses.
8 * Taken from baseline incidence rates in England in 2015 in women with BMI 27 (kg/m2) Note: Since the background incidence of breast cancer differs by EU country, the number of additional cases of breast cancer will also change proportionately.
5) +4 (0 – 9) * WHI study in women with no uterus, which did not show an increase of breast cancer. § When the analysis was restricted to women who had not used HRT prior to the study there was no increased risk apparent during the first 5 years of treatment: after 5 years the risk was higher than in non- users.
Endometrial cancer risk Postmenopausal women with a uterus The endometrial cancer risk is about 5 in every 1000 women with a uterus not using HRT. 4). Depending on the duration of estrogen-only use and estrogen dose, the increase in risk of endometrial cancer in epidemiology studies varied from between 5 and 55 extra cases diagnosed in every 1000 women between the ages of 50 and 65.
Adding a progestogen to estrogen-only therapy for at least 12 days per cycle can prevent this increased risk. 2)). 4). 56). For women aged 50 to 54 years taking 5 years of HRT, this results in about 1 extra case per 2000 users. In women aged 50 to 54 who are not taking HRT, about 2 women in 2000 will be diagnosed with ovarian cancer over a 5-year period.
e. deep vein thrombosis or pulmonary embolism. 4). 3) 5 (1-13) * Study in women with no uterus. Risk of coronary artery disease • The risk of coronary artery disease is slightly increased in […]
• Epilepsy. • Asthma. • Otosclerosis. Reasons for immediate withdrawal of therapy Therapy should be discontinued in case a contra-indication is discovered and in the following situations: • Jaundice or deterioration in liver function.
• Significant increase in blood pressure. • New onset of migraine-type headache. • Pregnancy. Endometrial hyperplasia and carcinoma • In women with an intact uterus the risk of endometrial hyperplasia and carcinoma is increased when estrogens are administered alone for prolonged periods.
8). After stopping treatment risk may remain elevated for at least 10 years. • The addition of a progestogen cyclically for at least 12 days per month/28 day cycle or continuous combined estrogen-progestogen therapy in non-hysterectomised women prevents the excess risk associated with estrogen-only HRT.
625 mg and patches > 50 μg/day the endometrial safety of added progestogens has not been demonstrated. • Break-through bleeding and spotting may occur during the first months of treatment. If break-through bleeding or spotting appears after some time on therapy, or continues after treatment has been discontinued, the reason should be investigated, which may include endometrial biopsy to exclude endometrial malignancy.
• Unopposed estrogen stimulation may lead to premalignant or malignant transformation in the residual foci of endometriosis. Therefore, the addition of progestogens to estrogen replacement therapy should be considered in women who have undergone hysterectomy because of endometriosis, if they are known to have residual endometriosis.
Breast cancer The overall evidence shows an increased risk of breast cancer in women taking combined estrogen- progestogen or estrogen-only HRT, that is dependent on the duration of taking HRT. 8). Estrogen – only therapy • The WHI trial found no increase in the risk of breast cancer in hysterectomised women using estrogen- only HRT.
8). Results from a large meta-analysis showed that after stopping treatment, the excess risk will decrease with time and the time needed to return to baseline depends on the duration of prior HRT use. When HRT was taken for more than 5 years, the risk may persist for 10 years or more.
HRT, especially estrogen-progestogen combined treatment, increases the density of mammographic images which may adversely affect the radiological detection of breast cancer. Ovarian cancer Ovarian cancer is much rarer than breast cancer.
Epidemiological evidence from a large meta-analysis suggests a slightly increased risk in women taking estrogen-only or combined estrogen-progestogen HRT, which becomes apparent within 5 years of use and diminishes over time after stopping.
8). e. deep vein thrombosis or pulmonary embolism. 8). • […]